The invention relates to an improved method and related devices for percutaneous placement of airway tubes into the tracheas of living bodies, a procedure known as a tracheostomy, and subsequent supportive maintenance tracheostomy.
Tracheostomies are the most common surgical procedure performed on critically ill patients. The procedure involves multiple steps to create and dilate a stoma and insert a tracheostomy tube, each additional step creating the possibility for error. Standard dilators, such as the BLUE RHINO manufactured by Cook Critical Care, and serial dilators, are inserted with a substantial, axially-inward force to dilate the patient's tissue, which, in addition to requiring significant physical strength on the part of the surgeon, may result in surgery-related complications such as bleeding; perforation of the adjacent vasculature, esophagus, and thyroid; pneumothorax and pneumomediastinum; subcutaneous and mediastinal emphysema; cartilage fractures; and suprastomal collapse. Further, dilators drag against the patient's tissue with a shear force and considerable friction, causing tissue trauma resulting in pain, slow healing, as well as, potentially, dysphagia, extensive scarring and disfiguration. Finally, insertion of a dilator may cause infection as a result of dragging or “tracking” microbes into the trachea from the skin of the entry site or from subcutaneous layers.
After the patient's tissues are dilated, insertion of a standard tracheostomy tube, such as the SHILEY manufactured by Covidien, creates a similar shear force and friction, with the same potential for complications, as the insertion of a dilator. Additionally, while in use, the tracheostomy tube can create additional complications such as tissue erosion, fibrotic, scar and granulation tissue formation and necrosis, which can result in tracheal stenosis necessitating surgical repair. Also, the interior of the trachea includes a layer of potentially infectious material known as biofilm. Biofilm may adhere to and build up on the tracheostomy tube leading to device and airway bacterial colonization, subsequent local infection, and, finally, systemic infection such as the frequent and often fatal complication of ventilator-associated pneumonia.
It is an object of this invention to simplify the procedure and reduce the number of components and steps required for tracheostomy.
It is a further object of this invention to provide a device and method that require less axial force to dilate patient tissue and less shear and frictional force to insert an airway into the patient's trachea.
It is a further object of this invention to provide a device and method that reduce the potential of infection and other complications associated with tracheostomy.
It is a further object of this invention to provide a device and method that reduce tissue trauma such as rubbing frictional and pressure necrosis, scarring, and granulation produced by a tracheostomy tube while in situ in a trachea.